MAUDE Adverse Event Report: MEDICAL ILLUMINATION INTRNATION INC. MI-1000; MINOR SURGICAL LIGHT

Model Number	061524
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer complaint #(b)(4) was issued for a mi-1000 led light system (model: 061524, s/n:(b)(4)).The light head was received and sent to engineering for failure analysis.The customer claims that the light has been in service for one (1) year before the light head separated from the yoke and fell from the spring arm being caught/suspended by the electrical wiring.The initial review was that the yoke (1002811) failed where it attached to the light head.The yoke was not included with the returned light head so the root cause analysis cannot be performed empirically.The analysis began with the inspection of the light head and the associated components returned with the unit.Upon visual inspection, the retaining ring measured correctly dimensionally but was mis-colored and had very little spring tension when expanded.The thrust washers appeared normal dimensionally and visually.We compared the retaining ring to the retaining rings that we have in stock and there is a distinct difference in appearance.We also compared the spring-action of the retaining ring in the failed unit to several of the retaining rings that we have in stock and found that was a significant degradation of "memory" in that the retaining ring did not fully return to the set-size.Without the yoke (requested on (b)(6) 2021), we cannot definitively determine a root=cause of the failure.Our speculation is that the retaining ring did not fully accept the annealing and heat-treating process in the fabrication process of the spring material and over time the retaining ring lost enough of its spring-tension and it ultimately worked itself out of the groove.We did a visual inspection of the retaining ring in stock and all appeared to be consistent in color.We also sampled the spring-tension on 20 retaining rings and all appeared to be consistent in spring-tension.
Event or Problem Description
On february 5th, it was reported to medical illumination that a mi-1000 light head had separated from the yoke.There were no injuries reported.

• Brand Name: MI-1000
• Common Device Name: MINOR SURGICAL LIGHT
• Manufacturer (Section D): MEDICAL ILLUMINATION INTRNATION INC.; 547 library street; san fernando CA 91340
• MDR Report Key: 11405386
• Report Number: 2028295-2021-00003
• Device Sequence Number: 3631915
• Product Code: FST
• UDI-Device Identifier: 00816835020164
• UDI-Public: (01)00816835020164
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 061524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1